This invention relates generally to the sterilization of medical instruments and, more specifically, to the sterilization of the laryngoscope blades.
Presently, there is no standardized procedure for the cleaning and disinfecting of the laryngoscope blades. While certain sterilization procedures have been proposed--see for example, an October, 1974 article in the S.A. Medical Journal entitled "Sterilization of the Laryngoscope Blades" by Jay Carstens--it remains that blades are typically manually scrubbed in a sink, rinsed, and set aside to dry. There are a number of problems associated with this procedure, not the least of which is the fact that soap and water are not effective to kill bacteria. As a result, the unsterile blade, in subsequent use, may introduce harmful pathogens into the trachea and/or pharynx.
In addition, the sink itself and surrounding surfaces may be contaminated, thereby placing other personnel at risk.
The present invention has for its principal object the introduction of a standardized sterilization procedure for laryngoscope blades (or other medical instruments) through the utilization of a simple, easy-to-use, low cost and disposable sterilization unit which, as will be explained below, may be provided in a self-contained kit form. It is contemplated that the apparatus of this invention will be utilized primarily in the numerous and well known health care settings, such as anaesthesia and respiratory care departments, emergency rooms, intensive care units, ambulance units and the like.
In one exemplary embodiment, the sterilization unit includes a substantially upright, plastic container body which is substantially L-shaped in plan and which is formed to provide a plurality of chambers or compartments which open at the top of the container.
A first chamber defines soaking and scrubbing areas and includes a vertically oriented partition to differentiate the soaking area from the scrubbing area. The vertically oriented partition is provided with a plurality of apertures arranged along the height of the container so that cleaning/disinfecting solution is permitted to pass freely between the soaking and scrubbing areas in this first chamber. The scrubbing area of this first chamber is also provided with a plurality of thick but soft cleaning bristles from bottom to top, and protruding inwardly to the center of the scrubbing area. The manner in which the laryngoscope blade is scrubbed in this area will be described in greater detail below.
A second chamber, isolated from the above described first chamber, is utilized in a first rinsing stage following the scrubbing and soaking of the instrument.
A third chamber, adjacent the second chamber, provides a second rinse area and is substantially identical to the second chamber.
Each of the above described chambers is provided with a lid, preferably integrally hinged to the apparatus itself, and including conventional cooperating snap-on/off surfaces which permit the chambers to be closed to thereby prevent the spillage of the liquid therein.
The first chamber is also provided with a pair of injection ports aligned one above the other in a side wall of the unit which partially forms the soaking area of the first chamber. Each port includes a cylindrical projection extending outwardly from a container body side wall and provided with interior threads for receiving a pair of exteriorly threaded, disposable injection syringes. Each port surrounds a resilient rubber or polymer plug secured within the side wall and adapted to be penetrated by an associated syringe.
Each syringe is preferably of unitary plastic construction for ease of disposability as will be explained further hereinbelow. The syringes are employed to introduce into the soaking area of the first chamber, buffer and activating components, respectively, of a cleaning/disinfecting solution. While in this exemplary embodiment, two syringes are described for use in conjunction with the sterilization unit, the dimensions and number of syringes may be varied in accordance with: (1) a type of cleaning/disinfecting solution used and its recommended dilution prior to use; and (2) the volume of water needed to fill the scrub/soak areas of the first chamber. In any event, it is intended that each syringe be prefilled with the correct amount of one of the cleaning/disinfecting solution buffer or activating components in accordance with the solution requirements and the particular sterilization procedure. This arrangement is desirable in that a longer shelf life is provided since, once activated, many solutions are effective for relatively short periods of time, e.g., thirty days.
Each syringe is formed with a barrel portion and an injection needle portion. The latter is designed to receive a resilient plastic bellows or accordion-type cap, which protects users from the sharp needle point. In addition, the cap is designed to remain on the needle and to compress when the syringe is fully screwed into the injection port and to be punctured by the syringe needle. With continuation of the screwing action, the needle will thereafter also penetrate the resilient plug inserted with the side wall of the chamber. It will be appreciated that the compressed cap acts as a secondary seal around the plug to further insure against leakage. It will be further understood that the cleaning/disinfecting solution may then be directly injected into the soaking area of the first chamber, and that the solution will be free to pass between the soaking area and scrubbing area via the apertures provided in the partition wall separating these areas of the first chamber.
It is a further feature of this invention that each of the three above described chambers may be prefilled with correct amounts of sterile or non-sterile water if so desired. Thus, when the cleaning/disinfecting solution is injected into the soak/scrub areas of the first chamber, it will freely mix with the water already present therein.
It will be appreciated, of course, that in the event a cleaning/disinfecting solution is utilized which does not require activation via mixing of separate components, that the injection ports and syringes may be omitted from the container body.
In the exemplary embodiment described above, prefilled syringes are initially screwed into the injection ports so that the bellows cap is closely adjacent but not in engagement with the injection plug in the side wall. In this way, the syringes will be held in a stable position during shipping. The syringes may be further protected during shipping and handling by a removable snap-on/off plastic cover which may be attached directly to exterior walls of the container body so as to completely enclose the syringes.
Just below this removable cover, three reinforcing plates project outwardly away from the container to a point just beyond the lateral extent of the syringes. The combination of the container walls, removable cover and reinforcing plates provide good protection for the syringe and also impart a substantially rectangular, volumetric outline for the container which provides stability and which facilitates packaging and shipping.
It is another feature of this invention that the sterilization unit is adapted to be supported by a bracket which may be attached to a wall, pole, or other mounting surface.
In another aspect of the invention, a larger disposal container is provided which is capable of holding up to six (or more) of the above described sterilization units. Since the individual sterilization units, syringes, and outer disposable containers are all preferably constructed of plastic and/or rubber materials, the disposal container, filled with six "dirty" sterilization units, can be easily disposed of by, for example, incineration, without risk of contamination.
The following preferred procedure is utilized to clean and disinfect a laryngoscope blade in accordance with one exemplary embodiment of the invention. Upon receipt of the sterilization unit, which is intended for single use, or single patient use, the user will prefill the first, second and third compartments with the correct amount of sterile or non-sterile water if this has not already been done. The buffer and activating components of the disinfecting solution are then injected into the scrub/soak area of the first chamber to freely mix with the sterile water therein and to activate the solution. The laryngoscope blade (or other medical instrument) is then inserted into the scrubbing area of the first chamber and thereafter reciprocated in an upward and downward motion while rotating the instrument through the brush bristles to remove all debris and/or tissue from the blade. Thereafter, the laryngoscope blade is removed from the scrubbing area and placed in the soaking area of the first chamber. In this regard, a slot found near the handle of all conventional laryngoscope blades slips easily onto a lip surrounding the open end of any of the chambers so that the blade may hang from the upper edge of the unit while the blade portion is immersed in the solution or sterile water. Once the correct soak time has expired, the blade is removed and thereafter placed immediately into the second chamber in a first rinsing stage. Specifically, the laryngoscope blade is dipped into the first of the two rinsing chambers to remove the majority of the cleaning/disinfecting solution. The blade is then immediately dipped into the third chamber in a second rinsing stage. It is in this second rinsing stage that any diluted cleaning/disinfecting solution remaining on the blade will be removed. The blade is thereafter removed from the third chamber and set aside for drying.
It will be appreciated that the overall dimensions of the sterilization unit and the various chambers are subject to change (including the addition of more than two rinse chambers), depending upon which type of cleaning/disinfecting solution is used, the amount required to insure effective sterilization, and the type of instrument being cleaned. In addition, one or both of the above described syringes may be altered in size or eliminated altogether, depending on the type of cleaning/disinfecting solution used.
It will also be appreciated that the above described sterilization apparatus may also be used for medical scissors, hemostats, and the like. In addition, utilizing the same concept and by slightly altering the dimensions and shape of the container, the apparatus may be custom designed for use with different medical instruments, such as gynecological and dental instruments.
Additional objects and advantages of the invention will become apparent from the detailed description of the drawings which follows.